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FDA 510(k)

HEARTNAVIGATOR RELEASE 1

K-Number: K111245 · 2011-07-29

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2011-07-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEARTNAVIGATOR RELEASE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2011-07-29 under 510(k) number K111245. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTNAVIGATOR RELEASE 1?

HEARTNAVIGATOR RELEASE 1 is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K111245.

When did HEARTNAVIGATOR RELEASE 1 receive FDA 510(k) clearance?

HEARTNAVIGATOR RELEASE 1 received FDA 510(k) clearance on 2011-07-29, under 510(k) number K111245.

Who is the listed applicant for HEARTNAVIGATOR RELEASE 1?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARTNAVIGATOR RELEASE 1?

The FDA product code for HEARTNAVIGATOR RELEASE 1 is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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